Posted by Michael Wonder on 21 Dec 2016
KemPharm granted "fast track" designation for KP201/IR
20 December 2016 - KP201/IR could be the first single entity (APAP-free), immediate release hydrocodone product for pain analgesia with abuse-deterrent properties.
KemPharm today announced that its investigational new drug application for KP201/IR has been granted “fast track” designation by the U.S. FDA.
KP201/IR, KemPharm’s co-lead product candidate, is a single-entity benzhydrocodone hydrochloride immediate release abuse-deterrent prodrug for the treatment of acute pain.
KemPharm expects to initiate human clinical trials of KP201/IR in the first half of 2017.
